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Date: Thursday, February 29, 2024 14:56

Release 5.142
Metacam 5 mg/ml solution for injection for dogs and cats
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics, Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs, Pharmaceuticals: Locomotor (including navicular and osteoarthritis)
Active ingredient: Meloxicam
Product:Metacam® 5 mg/ml solution for injection for dogs and cats
Product index: Metacam 5 mg/ml solution for injection for dogs and cats
Incorporating:
Presentation
Clear yellow solution for injection. One ml contains 5 mg meloxicam as active substance and 150 mg ethanol as excipient.
Uses
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Dosage and administration
Dogs
Musculo-skeletal disorders
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Reduction of post-operative pain (over a period of 24 hours)
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4  ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Cats
Reduction of post-operative pain
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.
Contra-indications, warnings, etc
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Anaphylactoid reactions have been observed very rarely from post-marketing safety experience and should be treated symptomatically. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
• very common (more than 1 in 10 animals treated displaying adverse reactions)
• common (more than 1 but less than 10 animals in 100 animals treated)
• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
• rare (more than 1 but less than 10 animals in 10,000 animals treated)
• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
In case of overdose symptomatic treatment should be initiated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Pharmaceutical precautions
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 28 days.
Keep out of the sight and reach of children. For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.
Further information
Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Pharmacokinetic properties
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 mg/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.
In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.
Elimination
In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
UK(GB): Vm 04491/5025
UK(NI): EU/2/97/004/006 : 10 ml
UK(NI): EU/2/97/004/011 : 20 ml
Significant changes
GTIN
GTIN description:Metacam 5 mg/ml Solution for Injection for Dogs and Cats - 10ml
GTIN:5012917011302
GTIN description:Metacam 5 mg/ml Solution for Injection for Dogs and Cats - 20ml
GTIN:5012917011326